Multi-site Animal Assisted Intervention for Children With... | NCT04799119

Studies
Multi-site Animal Assisted Intervention for Children With DD and Their Family Dog

NCT04799119

Sponsor

Oregon State University

Status

Active, not recruiting

Last Update Posted

Nov 18, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Physical Activity
Social Wellbeing

Interventions

Do As I Do (DAID) dog training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2021Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Mar 11, 2021

First Submission Date that Met QC Criteria

Mar 11, 2021

First Posted Date

Mar 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Megan MacDonald, Professor, Oregon State UniversityPrincipal Investigator

Lead Sponsor

Oregon State UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study purpose is to evaluate a novel multidisciplinary approach to fostering a therapeutic partnership between the participants with developmental disabilities and the participants family dog. This will culminate in an Animal Assisted Intervention aimed at increasing activity levels, enhancing social support, and increasing feeling of responsibility and wellbeing within this population.

Detailed Description

The goal of this proposal is to evaluate a large scale novel multidisciplinary approach to fostering atherapeutic partnership between adolescents with developmental disabilities (DD) and the participants family dog. The investigators will evaluate imitative 'Do As I Do' (DAID) training into a unique Animal Assisted Intervention (AAI) aimed at increasing activity levels, enhancing social support by promoting a stronger dog-human bond, and increasing feelings of responsibility and wellbeing within this population.

The investigators propose to address the critical need for empirical evaluation of novel theoretically based multi-site animal assisted interventions through the following specific aims.

Specific Aim 1: To evaluate a novel multi-site DAID dog training intervention to promote physical activity in adolescents with developmental disabilities.

Specific Aim 2: To evaluate the impact of a multi-site DAID intervention on the adolescent's quality of life and feelings of social wellbeing.

Specific Aim 3: To evaluate the impact of a multi-site DAID intervention on the child-dog relationship and mutual wellbeing.

Participant Population: Adolescent participants with a developmental disability, between the ages of 10-17 years will be recruited through community-based programs/organizations associated with children with DDs in around our sites. A DD will be confirmed through parent report (e.g., initial recruitment conversations, and documented through the initial demographic questionnaire).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DAID dog training	Experimental	'Do As I Do' (DAID) dog training employs operant conditioning to train dogs to copy the behavior of their owner upon hearing the verbal cue 'Do it', similar to teaching a dog the rules behind the game 'Simon Says'. Once this rule has been established and generalized, something that can be achieved in dogs by practicing with only 3-6 initially learned behaviors, owners can demonstrate new actions and use the cue 'Do it' to prompt a matched, imitative, behavioral response.	Behavioral: Do As I Do (DAID) dog training
Control	No Intervention	No intervention (waitlisted and will be provided with the experimental condition post-study completion).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Do As I Do (DAID) dog training	Behavioral	Children and their family dog will participate in this dog training program.	DAID dog training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical Activity	Physical activity will be measure through accelerometry.	One year

Secondary Outcomes

Measure	Description	Time Frame
Social well-being	Pediatric Quality of Life Inventory	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 10-17 years
Developmental disability (per parental report)
Possesses family dog
Participant can follow basis instructions.

Exclusion Criteria:

Cannot follow basic instructions.
Non english-speakers.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Megan MacDonald	Oregon State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon State University		Corvallis	Oregon	97331	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to the age range of the participants and targeted sample of children with disabilities as well as the small sample size (N=100), data will not be uploaded to NIH sharing tools.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided